510(k) K971756 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
MEDTRONIC MODEL 3998 LEAD
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 3, 1998 |
| Received | May 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | Medtronic Neuromodulation Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Terminated |
GZB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.